Disposable article having a biosensor

ABSTRACT

A disposable article to be fitted to a wearer comprising a biosensor including at least one bio-recognition element. The biosensor is adapted to detect a target biological analyte in bodily waste or on the wearer&#39;s skin.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.09/299,399, filed Apr. 26, 1999, now U.S. Pat. No. 6,713,660, which is acontinuation-in-part of U.S. application Ser. No. 09/107,563, filed onJun. 29, 1998 now U.S. Pat. No. 6,093,869.

FIELD OF THE INVENTION

The present invention relates to disposable articles and, moreparticularly, to disposable articles having biosensors having abio-recognition element that detects microorganisms and/or otherbiomolecules in bodily waste.

BACKGROUND OF THE INVENTION

Today, disposable articles, such as diapers, adult incontinence briefs,sanitary napkins and tampons, are widely used in infant and toddler careand in the care of incontinent adults as a means of containing,isolating and disposing of bodily wastes. These articles have generallyreplaced reusable, washable cloth garments as the preferred means forthese applications because of their convenience and reliability. Thedisposable articles respond to a defecation, urination or dischargeevent by absorbing or containing bodily wastes deposited on the article.Some disposable articles also signal a defecation, urination ordischarge event after it has occurred (e.g., wetness indicators,temperature change detection). Other disposable absorbent articles knownin the art comprise a chemically reactive means to detect varioussubstances in the wearer's waste(s). However, none of these specificallydetect target potentially pathogenic microorganisms such as bacteria,viruses, fungi, and parasites (e.g., protozoans) and/or relatedbiomolecules, all of which require a high degree of selectivity (i.e.,specificity) and sensitivity versus purely chemical agents.Additionally, the articles do not predict when a health-related event isabout to occur and signal wearer or caregiver that prophylactic orremedial action is required prior to the onset of clinically observablesymptoms.

SUMMARY OF THE INVENTION

The present invention is directed to a disposable article to be fittedto a wearer comprising a biosensor including at least onebio-recognition element. The biosensor is adapted to detect a targetbiological analyte in bodily waste or on the wearer's skin. Morepreferably, the absorbent article of the present invention may comprisea biosensor adapted to detect one or more specific microorganisms and/orrelated biomolecules and to signal the caretaker, the wearer, or anactuator of the occurrence.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of the article made in accordance with the presentinvention in a flat-out state with portions of the structure beingcut-away to more clearly show the construction of the article, whereinthe article is a diaper.

FIG. 2 shows a perspective view of a bodily waste isolation device ofthe present invention in a compressed state before activation.

FIG. 2A shows a sectional view taken along line 2A-2A of FIG. 2.

FIG. 3A shows an ideal output function of a discontinuous responsivesystem of the present invention having a single threshold level.

FIG. 3B shows an ideal output function of a discontinuous responsivesystem of the present invention having multiple threshold levels.

FIG. 4A shows an exemplary output function of a discontinuous responsivesystem of the present invention along with the first, second and thirdderivatives of the output function.

FIG. 4B shows a transfer function of a control system having a series offirst order lags having an equal time constant.

FIGS. 5A and 5B show an embodiment of a responsive system of the presentinvention including an electrically sensitive gel.

FIGS. 6A, 6B and 6C show another embodiment of a responsive system ofthe present invention including an electrically sensitive gel.

FIG. 7 is a perspective view of a waste bag embodiment of the presentinvention.

FIG. 8 is a perspective view of an absorbent article including a wastebag.

DETAILED DESCRIPTION OF THE INVENTION

As used herein, the term “absorbent article” refers to devices whichabsorb and contain body exudates, and more specifically, refers todevices which are placed against or in proximity to the body of thewearer to absorb and contain the various exudates discharged from thebody. The term “disposable” is used herein to describe absorbentarticles which generally are not intended to be laundered or otherwiserestored or reused as an absorbent article (i.e., they are intended tobe discarded after a single use and, preferably, to be recycled,composted or otherwise disposed of in an environmentally compatiblemanner). (As used herein, the term “disposed” is used to mean that anelement(s) of the diaper is formed (joined and positioned) in aparticular place or position as a unitary structure with other elementsof the diaper or as a separate element joined to another element of thediaper. As used herein, the term “joined” encompasses configurationswhereby an element is directly secured to another element by affixingthe element directly to the other element, and configurations whereby anelement is indirectly secured to another element by affixing the elementto intermediate member(s) which in turn are affixed to the otherelement.) A “unitary” absorbent article refers to absorbent articleswhich are formed of separate parts united together to form a coordinatedentity so that they do not require separate manipulative parts like aseparate holder and liner. A preferred embodiment of an absorbentarticle of the present invention is a unitary disposable absorbentarticle, such as the diaper 20 shown in FIG. 1. As used herein, the term“diaper” refers to an absorbent article generally worn by infants andincontinent persons about the lower torso. The present invention is alsoapplicable to other absorbent or non-absorbent articles such asincontinence briefs, incontinence undergarments, absorbent inserts,diaper holders and liners, colostomy bags for a natural or artificialanus, feminine hygiene garments, tampons, wipes, disposable towels,tissues, water absorbing articles, oil absorbing articles, spill cleanupbags, desiccant bags, disposable mops, bandages, therapeutic wraps,supports, disposable heating pads and the like.

FIG. 1 is a plan view of the diaper 20 of the present invention in aflat-out, state with portions of the structure being cut-away to moreclearly show the construction of the diaper 20. The portion of thediaper 20 which faces the wearer is oriented towards the viewer. Asshown in FIG. 1, the diaper 20 preferably comprises a liquid pervioustopsheet 24; a liquid impervious backsheet 26; an absorbent core 28,which is preferably positioned between at least a portion of thetopsheet 24 and the backsheet 26; side panels 30; elasticized leg cuffs32; an elastic waist feature 34; and a fastening system generallydesignated 40. Diaper 20 is shown in FIG. 1 to have a first waist region36, a second waist region 38 opposed to the first waist region 36 and acrotch region 37 located between the first waist region and the secondwaist region. The periphery of the diaper 20 is defined by the outeredges of the diaper 20 in which the longitudinal edges 50 run generallyparallel to the longitudinal centerline 100 of the diaper 20 and the endedges 52 run between the longitudinal edges 50 generally parallel to thelateral centerline 110 of the diaper 20.

The chassis 22 of the diaper 20 comprises the main body of the diaper20. The chassis 22 comprises at least a portion of the absorbent core 28and preferably an outer covering layer including the topsheet 24 and thebacksheet 26. If the absorbent article comprises a separate holder and aliner, the chassis 22 generally comprises the holder and the liner. (Forexample, the holder may comprise one or more layers of material to formthe outer cover of the article and the liner may comprise an absorbentassembly including a topsheet, a backsheet, and an absorbent core. Insuch cases, the holder and/or the liner may include a fastening elementwhich is used to hold the liner in place throughout the time of use.)For unitary absorbent articles, the chassis 22 comprises the mainstructure of the diaper with other features added to form the compositediaper structure. While the topsheet 24, the backsheet 26, and theabsorbent core 26 may be assembled in a variety of well knownconfigurations, preferred diaper configurations are described generallyin U.S. Pat. No. 3,860,003 entitled “Contractible Side Portions forDisposable Diaper” which issued to Kenneth B. Buell on Jan. 14, 1975;U.S. Pat. No. 5,151,092 issued to Buell on Sep. 9, 1992; and U.S. Pat.No. 5,221,274 issued to Buell on Jun. 22, 1993; and U.S. Pat. No.5,554,145 entitled “Absorbent Article With Multiple Zone StructuralElastic-Like Film Web Extensible Waist Feature” which issued to Roe etal. on Sep. 10, 1996; U.S. Pat. No. 5,569,234 entitled “DisposablePull-On Pant” which issued to Buell et al. on Oct. 29, 1996; U.S. Pat.No. 5,580,411 entitled “Zero Scrap Method For Manufacturing Side PanelsFor Absorbent Articles” which issued to Nease et al. on Dec. 3, 1996;and U.S. patent application Ser. No. 08/915,471 entitled “AbsorbentArticle With Multi-Directional Extensible Side Panels” filed Aug. 20,1997 in the name of Robles et al.; each of which is incorporated hereinby reference.

The backsheet 26 is generally that portion of the diaper 20 positionedadjacent the garment facing surface 45 of the absorbent core 28 whichprevents the exudates absorbed and contained therein from soilingarticles which may contact the diaper 20, such as bedsheets andundergarments. The backsheet 26 may be joined to the topsheet 24, theabsorbent core 28 or any other element of the diaper 20 by anyattachment means known in the art. Suitable backsheet films includethose manufactured by Tredegar Industries Inc. of Terre Haute, Ind. andsold under the trade names X15306, X10962 and X10964. Other suitablebacksheet materials may include breathable materials such as woven webs,nonwoven webs, composite materials such as film-coated nonwoven webs,and microporous films such as manufactured by Mitsui Toatsu Co., ofJapan under the designation ESPOIR NO; EXXON Chemical Co., of Bay City,Tex., under the designation EXXAIRE; or monolithic films such asmanufactured by Clopay Corporation, Cincinnati, Ohio under the nameHYTREL blend P18-3097. Such breathable composite materials are describedin greater detail in PCT Application No. WO 95/16746, published on Jun.22, 1995 in the name of E. I. DuPont; copending U.S. Pat. No. 5,865,823issued to Curro on Feb. 2, 1999; U.S. Pat. No. 5,571,096 issued toDobrin et al. on Nov. 5, 1996. Each of these references is herebyincorporated by reference herein.

The backsheet 26, or any portion thereof, may be elastically extensiblein one or more directions. In one embodiment, the backsheet 26 maycomprise a structural elastic-like film (“SELF”) web. A structuralelastic-like film web is an extensible material that exhibits anelastic-like behavior in the direction of elongation without the use ofadded elastic materials. SELF webs suitable for the present inventionare described in U.S. Pat. No. 5,518,801 entitled Web MaterialsExhibiting Elastic-Like Behavior, which issued to Chappell, et, al. onMay 21, 1996, which is incorporated herein by reference. In alternateembodiments, the backsheet 26 may comprise elastomeric films, foams,strands, or combinations of these or other suitable materials withnonwovens or synthetic films.

The topsheet 24 is preferably compliant, soft feeling, andnon-irritating to the wearer's skin. A suitable topsheet 24 may bemanufactured from a wide range of materials, such as porous foams;reticulated foams; apertured plastic films; or woven or nonwoven webs ofnatural fibers (e.g., wood or cotton fibers), synthetic fibers (e.g.,polyester or polypropylene fibers), or a combination of natural andsynthetic fibers. If the topsheets include fibers, the fibers may bespunbond, carded, wet-laid, meltblown, hydroentangled, or otherwiseprocessed as is known in the art. One suitable topsheet 24 comprising aweb of staple length polypropylene fibers is manufactured by Veratec,Inc., a Division of International Paper Company, of Walpole,Massachusetts under the designation P-8.

Suitable formed film topsheets are described in U.S. Pat. No. 3,929,135,entitled “Absorptive Structures Having Tapered Capillaries”, whichissued to Thompson on Dec. 30, 1975; U.S. Pat. No. 4,324,246 entitled“Disposable Absorbent Article Having A Stain Resistant Topsheet”, whichissued to Mullane, et al. on Apr. 13, 1982; U.S. Pat. No. 4,342,314entitled “Resilient Plastic Web Exhibiting Fiber-Like Properties”, whichissued to Radel, et al. on Aug. 3, 1982; U.S. Pat. No. 4,463,045entitled “Macroscopically Expanded Three-Dimensional Plastic WebExhibiting Non-Glossy Visible Surface and Cloth-Like TactileImpression”, which issued to Ahr, et al. on Jul. 31, 1984; and U.S. Pat.No. 5,006,394 “Multilayer Polymeric Film” issued to Baird on Apr. 9,1991. Other suitable topsheets 30 are made in accordance with U.S. Pat.Nos. 4,609,518 and 4,629,643 which issued to Curro et al. on Sep. 2,1986 and Dec. 16, 1986, respectively, and both of which are incorporatedherein by reference. Such formed films are available from The Procter &Gamble Company of Cincinnati, Ohio as “DRI-WEAVE” and from TredegarCorporation of Terre Haute, Ind. as “CLIFF-T.”

Preferably, the topsheet 24 is made of a hydrophobic material or istreated to be hydrophobic in order to isolate the wearer's skin fromliquids contained in the absorbent core 28. If the topsheet 24 is madeof a hydrophobic material, preferably at least the upper surface of thetopsheet 24 is treated to be hydrophilic so that liquids will transferthrough the topsheet more rapidly. The topsheet 24 can be renderedhydrophilic by treating it with a surfactant or by incorporating asurfactant into the topsheet. Suitable methods for treating the topsheet24 with a surfactant include spraying the topsheet 24 material with thesurfactant and immersing the material into the surfactant. A moredetailed discussion of such a treatment and hydrophilicity is containedin U.S. Pat. No. 4,988,344 entitled “Absorbent Articles with MultipleLayer Absorbent Layers” issued to Reising, et al. on Jan. 29, 1991 andU.S. Pat. No. 4,988,345 entitled “Absorbent Articles with RapidAcquiring Absorbent Cores” issued to Reising on Jan. 29, 1991. A moredetailed discussion of some suitable methods for incorporatingsurfactant in the topsheet can be found in U.S. Statutory InventionRegistration No. H1670, published on Jul. 1, 1997 in the names of Azizet al. Each of these references is hereby incorporated by referenceherein.

Any portion of the topsheet 24 or other components of the article may becoated with a lotion as is known in the art. Examples of suitablelotions include those described in U.S. Pat. No. 5,607,760 entitled“Disposable Absorbent Article Having A Lotioned Topsheet Containing anEmollient and a Polyol Polyester Imobilizing Agent” which issued to Roeon Mar. 4, 1997; U.S. Pat. No. 5,609,587 entitled “Diaper Having ALotion Topsheet Comprising A Liquid Polyol Polyester Emollient And AnImmobilizing Agent” which issued to Roe on Mar. 11, 1997; U.S. Pat. No.5,635,191 entitled “Diaper Having A Lotioned Topsheet Containing APolysiloxane Emollient” which issued to Roe et al. on Jun. 3, 1997; andU.S. Pat. No. 5,643,588 entitled “Diaper Having A Lotioned Topsheet”which issued to Roe et al. on Jul. 1, 1997. The lotion may functionalone or in combination with another agent as the hydrophobizingtreatment described above. The topsheet may also include or be treatedwith antibacterial agents, some examples of which are disclosed in PCTPublication No. WO 95/24173 entitled “Absorbent Articles ContainingAntibacterial Agents in the Topsheet For Odor Control” which waspublished on Sep. 14, 1995 in the name of Theresa Johnson. Further, thetopsheet 24, the backsheet 26 or any portion of the topsheet orbacksheet may be embossed and/or matte finished to provide a more clothlike appearance.

The absorbent core 28 may comprise any absorbent material which isgenerally compressible, conformable, non-irritating to the wearer'sskin, and capable of absorbing and retaining liquids such as urine andother certain body exudates. The absorbent core 28 may be manufacturedin a wide variety of sizes and shapes (e.g., rectangular, hourglass,“T”-shaped, asymmetric, etc.) and may comprise a wide variety ofliquid-absorbent materials commonly used in disposable diapers and otherabsorbent articles such as comminuted wood pulp, which is generallyreferred to as airfelt. Examples of other suitable absorbent materialsinclude creped cellulose wadding; meltblown polymers, including coform;chemically stiffened, modified or cross-linked cellulosic fibers;tissue, including tissue wraps and tissue laminates; absorbent foams;absorbent sponges; superabsorbent polymers; absorbent gelling materials;or any other known absorbent material or combinations of materials.

The configuration and construction of the absorbent core 28 may also bevaried (e.g., the absorbent core(s) or other absorbent structure(s) mayhave varying caliper zones, a hydrophilic gradient, a superabsorbentgradient, or lower average density and lower average basis weightacquisition zones; or may comprise one or more layers or structures).

Exemplary absorbent structures for use as the absorbent assemblies aredescribed in U.S. Pat. No. 4,610,678 entitled “High-Density AbsorbentStructures” issued to Weisman et al. on Sep. 9, 1986; U.S. Pat. No.4,673,402 entitled “Absorbent Articles With Dual-Layered Cores” issuedto Weisman et al. on Jun. 16, 1987; U.S. Pat. No. 4,834,735, entitled“High Density Absorbent Members Having Lower Density and Lower BasisWeight Acquisition Zones”, issued to Alemany et al. on May 30, 1989;U.S. Pat. No. 4,888,231 entitled “Absorbent Core Having A Dusting Layer”issued to Angstadt on Dec. 19, 1989; U.S. Pat. No. 5,137,537 entitled“Absorbent Structure Containing Individualized, Polycarboxylic AcidCrosslinked Wood Pulp Cellulose Fibers” which issued to Herron et al. onAug. 11, 1992; U.S. Pat. No. 5,147,345 entitled “High EfficiencyAbsorbent Articles For Incontinence Management” issued to Young et al.on Sep. 15, 1992; U.S. Pat. No. 5,342,338 entitled “Disposable AbsorbentArticle For Low-Viscosity Fecal Material” issued to Roe on Aug. 30,1994; U.S. Pat. No. 5,260,345 entitled “Absorbent Foam Materials ForAqueous Body Fluids and Absorbent Articles Containing Such Materials”issued to DesMarais et al. on Nov. 9, 1993; U.S. Pat. No. 5,387,207entitled “Thin-Until-Wet Absorbent Foam Materials For Aqueous BodyFluids And Process For Making Same” issued to Dyer et al. on Feb. 7,1995; and U.S. Pat. No. 5,625,222 entitled “Absorbent Foam Materials ForAqueous Fluids Made From high Internal Phase Emulsions Having Very HighWater-To-Oil Ratios” issued to DesMarais et al. on Jul. 22, 1997. Eachof these patents is incorporated herein by reference.

The diaper 20 may also comprise at least one elastic waist feature 34that helps to provide improved fit and containment. The elastic waistfeature 34 preferably extends at least longitudinally outwardly from atleast one waist edge 62 of the absorbent core 28 and generally forms atleast a portion of the end edge 52 of the diaper 20. Disposable diapersare often constructed so as to have two elastic waist features, onepositioned in the first waist region 36 and one positioned in the secondwaist region 38. Further, while the elastic waist feature 34 or any ofits constituent elements may comprise one or more separate elementsaffixed to the diaper 20, the elastic waist feature 34 may beconstructed as an extension of other elements of the diaper 20, such asthe backsheet 26, the topsheet 24, or both the backsheet 26 and thetopsheet 24.

The elastic waist feature 34 may be constructed in a number of differentconfigurations including those described in U.S. Pat. No. 4,515,595issued to Kievit et al. on May 7, 1985; U.S. Pat. No. 4,710,189 issuedto Lash on Dec. 1, 1987; U.S. Pat. No. 5,151,092 issued to Buell on Sep.9, 1992; and U.S. Pat. No. 5,221,274 issued to Buell on Jun. 22, 1993.Other suitable waist configurations may include waistcap features suchas those described in U.S. Pat. No. 5,026,364 issued to Robertson onJun. 25, 1991 and U.S. Pat. No. 4,816,025 issued to Foreman on Mar. 28,1989. All of the above mentioned references are incorporated herein byreference.

The diaper 20 may also include a fastening system 40. The fasteningsystem 40 preferably comprises tape tabs and/or hook and loop fasteningcomponents, although any other known fastening means are generallyacceptable. Some exemplary fastening systems are disclosed in U.S. Pat.No. 3,848,594 entitled “Tape Fastening System for Disposable Diaper”issued to Buell on Nov. 19, 1974; U.S. Pat. No. 4,662,875 entitled“Absorbent Article” issued to Hirotsu et al. on May 5, 1987; U.S. Pat.No. 4,846,815 entitled “Disposable Diaper Having An Improved FasteningDevice” issued to Scripps on Jul. 11, 1989; U.S. Pat. No. 4,894,060entitled “Disposable Diaper With Improved Hook Fastener Portion” issuedto Nestegard on Jan. 16, 1990; U.S. Pat. No. 4,946,527 entitled“Pressure-Sensitive Adhesive Fastener And Method of Making Same” issuedto Battrell on Aug. 7, 1990; and the herein before referenced U.S. Pat.No. 5,151,092 issued to Buell on Sep. 9, 1992; and U.S. Pat. No.5,221,274 issued to Buell on Jun. 22, 1993. The fastening system mayalso provide a means for holding the article in a disposal configurationas disclosed in U.S. Pat. No. 4,963,140 issued to Robertson et al. onOct. 16, 1990. Each of these patents is incorporated herein byreference. In alternative embodiments, opposing sides of the garment maybe seamed or welded to form a pant. This allows the article to be usedas a pull-on type diaper, such as a training pant.

The diaper 20 may also comprise side panels 30. The side panels 30 maybe elastic or extensible to provide a more comfortable and contouringfit by initially conformably fitting the diaper 20 to the wearer andsustaining this fit throughout the time of wear well past when thediaper 20 has been loaded with exudates since the elasticized sidepanels 30 allow the sides of the diaper 20 to expand and contract.

While the diaper 20 of the present invention preferably has the sidepanels 30 disposed in the second waist region 38, the diaper 20 may beprovided with side panels 30 disposed in the first waist region 36 or inboth the first waist region 36 and the second waist region 38. The sidepanels 30 may be constructed in any suitable configurations. Examples ofdiapers with elasticized side panels are disclosed in U.S. Pat. No.4,857,067, entitled “Disposable Diaper Having Shirred Ears” issued toWood, et al. on Aug. 15, 1989; U.S. Pat. No. 4,381,781 issued toSciaraffa, et al. on May 3, 1983; U.S. Pat. No. 4,938,753 issued to VanGompel, et al. on Jul. 3, 1990; the herein before referenced U.S. Pat.No. 5,151,092 issued to Buell on Sep. 9, 1992; and U.S. Pat. No.5,221,274 issued to Buell on Jun. 22, 1993; U.S. Pat. No. 5,669,897issued to LaVon, et al. on Sep. 23, 1997 entitled “Absorbent ArticlesProviding Sustained Dynamic Fit”; U.S. patent application Ser. No.08/915,471 entitled “Absorbent Article With Multi-Directional ExtensibleSide Panels” filed Aug. 20, 1997 in the names of Robles, et al.; each ofwhich is incorporated herein by reference.

The diaper 20 preferably further includes leg cuffs 32 which provideimproved containment of liquids and other body exudates. Leg cuffs mayalso be referred to as leg bands, side flaps, barrier cuffs, or elasticcuffs. U.S. Pat. No. 3,860,003 describes a disposable diaper whichprovides a contractible leg opening having a side flap and one or moreelastic members to provide an elasticized leg cuff (a gasketing cuff).U.S. Pat. Nos. 4,808,178 and 4,909,803 issued to Aziz et al. on Feb. 28,1989 and Mar. 20, 1990, respectively, describe disposable diapers having“stand-up” elasticized flaps (barrier cuffs) which improve thecontainment of the leg regions. U.S. Pat. Nos. 4,695,278 and 4,795,454issued to Lawson on Sep. 22, 1987 and to Dragoo on Jan. 3, 1989,respectively, describe disposable diapers having dual cuffs, includinggasketing cuffs and barrier cuffs. In some embodiments, it may bedesirable to treat all or a portion of the leg cuffs with a lotion, asdescribed above.

Embodiments of the present invention may also include pockets forreceiving and containing waste, spacers which provide voids for waste,barriers for limiting the movement of waste in the article, compartmentsor voids which accept and contain waste materials deposited in thediaper, and the like, or any combinations thereof. Examples of pocketsand spacers for use in absorbent products are described in U.S. Pat. No.5,514,121 issued to Roe et al. on May 7, 1996, entitled “Diaper HavingExpulsive Spacer”; U.S. Pat. No. 5,171,236 issued to Dreier et al onDec. 15, 1992, entitled “Disposable Absorbent Article Having CoreSpacers”; U.S. Pat. No. 5,397,318 issued to Dreier on Mar. 14, 1995,entitled “Absorbent Article Having A Pocket Cuff”; U.S. Pat. No.5,540,671 issued to Dreier on Jul. 30, 1996, entitled “Absorbent ArticleHaving A Pocket Cuff With An Apex”; and PCT Application WO 93/25172published Dec. 3, 1993, entitled “Spacers For Use In Hygienic AbsorbentArticles And Disposable Absorbent Articles Having Such Spacer”; and U.S.Pat. No. 5,306,266, entitled “Flexible Spacers For Use In DisposableAbsorbent Articles”, issued to Freeland on Apr. 26, 1994. Examples ofcompartments or voids are disclosed in U.S. Pat. No. 4,968,312, entitled“Disposable Fecal Compartmenting Diaper”, issued to Khan on Nov. 6,1990; U.S. Pat. No. 4,990,147, entitled “Absorbent Article With ElasticLiner For Waste Material Isolation”, issued to Freeland on Feb. 5, 1991;U.S. Pat. No. 5,62,840, entitled “Disposable Diapers”, issued to Holt etal on Nov. 5, 1991; and U.S. Pat. No. 5,269,755 entitled “TrisectionTopsheets For Disposable Absorbent Articles And Disposable AbsorbentArticles Having Such Trisection Topsheets”, issued to Freeland et al onDec. 14, 1993. Examples of suitable transverse barriers are described inU.S. Pat. No. 5,554,142 entitled “Absorbent Article Having MultipleEffective Height Transverse Partition” issued Sep. 10, 1996 in the nameof Dreier et al.; PCT Patent WO 94/14395 entitled “Absorbent ArticleHaving An Upstanding Transverse Partition” published Jul. 7, 1994 in thename of Freeland, et al.; and U.S. Pat. No. 5,653,703 Absorbent ArticleHaving Angular Upstanding Transverse Partition, issued Aug. 5, 1997 toRoe, et al. All of the above-cited references are hereby incorporated byreference herein.

Embodiments of the present invention may also include a waste managementdevice 110 such as is shown in FIG. 7. The waste management device 110may include a waste bag 111 to collect feces, urine or both. The wastebag 111 may have an aperture 121 and a flange 112 surrounding theaperture for preferably adhesive attachment to the perianal area of awearer. Further, the waste management device 110 has been found to beparticularly useful and beneficial when used in conjunction with agarment, or diaper, preferably a disposable diaper. One example of anabsorbent article, such as the diaper 120 including a waste bag 111 isshown in FIG. 8. If associated with a diaper 120 or other garment, thewaste bag 111 may be disposed on or joined to any surface of thearticle. In one embodiment, the waste bag 111 is joined to the topsheet124 of the diaper 120.

The waste bag 111 is preferably a flexible receptacle for thecontainment of excreted fecal matter or urine. Thus, the waste bag 111is preferably liquid impermeable, and yet it may be breathable. Further,the waste bag 111 is designed of sufficient strength to withstandtypical wearing conditions, such as sitting.

The waste bag 111 may comprise one or multiple layers. In oneembodiment, the waste bag 111 may comprise three layers, preferably onefilm and two non-woven layers. The layers of the bag material maycomprise any material, preferably so that the bag is liquid impervious.In a preferred embodiment of the present invention a laminate may beformed from a non-woven layer and a film.

Suitable film materials for any of the film layers preferably comprise athermoplastic material. The thermoplastic material can may be vaporpervious or impervious and can be selected from among all types ofhot-melt adhesives, polyolefins especially polyethylene, polypropylene,amorphous polyolefins, and the like; material containing meltablecomponents comprising fibres or polymeric binders including naturalfibres such as cellulose—wood pulp, cotton, jute, hemp; synthetic fibressuch as fibreglass, rayon, polyester, polyolefin, acrylic, polyamid,aramid, polytetrafluroethylene metal, polyimide; binders such asbicomponent high melt/low melt polymer, copolymer polyester, polyvinylchloride, polyvinyl acetate/chloride copolymer, copolymer polyamide,materials comprising blends wherein some of the constituent materialsare not meltable; air and vapour permeable materials includingmicroporous films such as those described above with respect to thebacksheet and monolithic breathable materials such as HYTREL™ availablefrom DuPont and Pebax™ available from ELF Atochem, France.

The waste bag 111 may have any shape or size. Preferred shapes includeflat circular type bags, cone shaped bags, truncated cone shaped bagsand pyramidal or truncated pyramidal shaped bags and flat T shaped bags.Further, the waste bag 111 may be provided from a unitary piece ofmaterial or a number of separate pieces of material which may beidentical or different and which may be sealed at their respectiveperipheries.

The waste bag 111 may also contain absorbent material. The absorbentmaterial may comprise any absorbent material which is capable ofabsorbing and retaining liquids. The absorbent material may comprise awide variety of liquid-absorbent materials commonly used in disposablediapers and other absorbent articles. Some examples are described hereinwith respect to the absorbent core.

The waste bag 111 is provided with an aperture 121 whereby fecal matteror urine is received from the body prior to storage within the bagcavity. The aperture 121 is preferably surrounded by a flange 112 andmay be provided in any shape or size, such as circular, oblong, heartshaped and may be symmetrical or asymmetrical, preferably the aperturehas an oblong configuration either in the longitudinal or in thetransversal direction. The flange may comprise projections designed tofit the perineal, genital and/or coccygeal area of the wearer.

The flange 112 should be made of soft, flexible and malleable materialto allow easy placement of the flange 112 to the perianal or uro-genitalarea. Typical materials include nonwoven materials, wovens, open celledthermoplastic foams, closed-cell thermoplastic foams, composites of opencelled foams and stretch nonwoven, and films.

The waste bag 111 preferably further comprises an attachment means tosecure the device to the wearer. Such means may comprise straps and or abody-compatible pressure sensitive adhesive applied to the wearer facingportion of the waste bag 111 or the flange. Any skin-friendly waterresistant pressure sensitive adhesive may be used to attach the deviceto the perianal or uro-genital area of the wearer, such as hydrocolloidadhesives and hydrogel adhesives. Particularly effective adhesives inproviding the desired adhesive properties to secure the flange to theskin of the wearer at the sensitive perianal area, while allowing forrelatively painless application and removal, are formed fromcrosslinking polymers with a plasticizer to form a 3-dimensional matrix.

The article 20 preferably also includes at least one biosensor 60. Asused herein, the term “biosensor” is defined as a component comprisingone or more biologically reactive means being adapted to detect one ormore target pathogenic microorganisms or related biomolecules (e.g., anenzyme sensor, organella sensor, tissue sensor, microorganism sensor,immunosensor or electrochemical sensor), additionally having thecapability to provide a signal of said detection to the wearer,caretaker, or an actuator. The term “biologically reactive” is definedas having the capability to selectively interact with, and preferablybind, target pathogenic microorganisms and/or related biomolecules asdescribed herein. Generally, biosensors function by providing a means ofspecifically binding, and therefore detecting, a target biologicallyactive analyte. In this way, the biosensor is highly selective, evenwhen presented with a mixture of many chemical and biological entities,such as feces. Chemical sensors, on the other hand, which rely onchemically reactive means, generally do not have either the highselectivity or the amplification properties of biosensors and,therefore, are not well suited to detect biologically reactive analytes,especially when they are present in low concentrations and/or in acomplex media such as bodily waste. Often the target biological analyteis a minor component of a complex mixture comprising a multiplicity ofbiological and other components. Thus, in many biosensor applications,detection of target analytes to the parts-per-billion,parts-per-trillion, or even lower levels is necessary. Accordingly,discrimination ratios of about 10⁷-10⁸ or greater may be required forthe biosensor to recognize the target biological analyte in a complexmixture.

The biosensor of the present invention comprises a bio-recognitionelement, or molecular recognition element, that provides the highlyspecific binding or detection selectivity for a particular analyte. Thebio-recognition element, or system, may be a biologically derivedmaterial such as an enzyme or sequence of enzymes; an antibody; amembrane receptor protein; DNA; an organelle, a natural or syntheticcell membrane; an intact or partial viable or nonviable bacterial, plantor animal cell; or a piece of plant or mammalian tissues, and generallyfunctions to interact specifically with a target biological analyte. Thebio-recognition element is responsible for the selective recognition ofthe analyte and the physico-chemical signal that provides the basis forthe output signal.

Biosensors may include biocatalytic biosensors, and bioaffinitybiosensors. In biocatalytic biosensor embodiments, the bio-recognitionelement is “biocatalytic” and may comprise an enzyme, organelle, pieceof plant or mammalian tissue, or whole cells, the selective bindingsites “turn over” (i.e., can be used again during the detectionprocess), resulting in a significant amplification of the input signal.Biocatalytic sensors such as these are generally useful for real-time,continuous sensing.

Bioaffinity sensors are generally applicable to bacteria, viruses, andtoxins and include chemoreceptor-based biosensors and/or immunologicalsensors (i.e. immunosensors). Chemoreceptors are complex biomolecularmacroassemblies responsible, in part, for a viable organism's ability tosense chemicals in its environment with high selectivity.Chemoreceptor-based biosensors comprise one or more natural or syntheticchemoreceptors associated with a means to provide a signal (visual,electrical, etc.) of the presence or concentration of a targetbiological analyte. In certain embodiments, the chemoreceptor may beassociated with an electrode (i.e., an electrical transducer) so as toprovide a detectable electrical signal. Chemoreceptors may include wholeor partial nerve bundles (e.g., from antennae or other sensing organs)and/or whole or partial natural or synthetic cell membranes. On theother hand, the bio-recognition elements of immunosensors are generallyantibodies. Antibodies are highly specific and can be made towardbacteria, viruses, fragments of microorganisms (e.g., bacterial cellwalls, parasite eggs or portions thereof, etc.), and large biomolecules.Suitable antibodies may be monoclonal or polyclonal. In any case,bioaffinity biosensors are generally irreversible because the receptorsites of the biosensor become saturated when exposed to the targetbiological analyte.

In certain embodiments, biocatalytic bioaffinity biosensors may becombined, such as RNA/DNA probes or other high-affinity binding systemswherein the initial bio-recognition event is followed by biologicalamplification of the signal. For example, a specific bacteria may bedetected by a biosensor comprising genetic material, such as DNA, as abio-recognition element and PCR (i.e., polymerase chain reaction)amplification to detect small numbers of organisms, preferably less thanor equal to about 500. Biocatalytic and bioaffinity biosensor systemsare described in more detail in Journal of Chromatography, 510 (1990)347-354 and in the Kirk-Othmer Encyclopedia of Chemical Technology,4^(th) ed. (1992), John Wiley & Sons, NY, the disclosure of which isincorporated by reference herein.

The biosensors of the present invention preferably detect biologicallyactive analytes related to impending (i.e., future presentation ofsymptoms is likely) or current human systemic disease states, including,but not limited to, pathogenic bacteria, parasites (e.g., any stage ofthe life cycle, including eggs or portions thereof, cysts, or matureorganisms), viruses, fungi such as Candida albicans, antibodies topathogens, and/or microbially produced toxins. Additionally, thebiosensor may target biologically active analytes related to impendingor current localized health issues, such as stress proteins (e.g.,cytokines) and IL-1α (interleukin 1-alpha) that may precede the clinicalpresentation of skin irritation or inflammation. In preferredembodiments, the biosensor functions as a proactive sensor, detectingand signaling the wearer or caretaker of the impending condition priorto the presentation of clinical symptoms. This allows time to administerprophylactic or remedial treatments to the wearer which cansignificantly reduce, if not prevent, the severity and duration of thesymptoms. Further, the biosensor 60, by detecting the presence of atarget biological analyte in the wearer's bodily waste (e.g., feces),may detect residual contamination on a surface, such as skin, in contactwith the biosensor, and provide and appropriate signal.

The physico-chemical signal generated by the bio-recognition element orelements may be communicated visually to the wearer or caretaker (i.e.,via a color change visible to the human eye). Other embodiments mayproduce optical signals, which may require other instrumentation toenhance the signal. These include fluorescence, bioluminescence, totalinternal reflectance resonance, surface plasmon resonance, Raman methodsand other laser-based methods. Exemplary surface plasmon resonancebiosensors which may comprise bioconjugate surfaces as bio-recognitionelements are available as IBIS I and IBIS II from XanTec Analysensystemeof Muenster, Germany. Alternatively, the signal may be processed via anassociated transducer which, for example, may produce an electricalsignal (e.g., current, potential, inductance, or impedance) that may bedisplayed (e.g., on a readout such as an LED or LCD display) or whichtriggers an audible or tactile (e.g., vibration) signal or which maytrigger an actuator, as described herein. The signal may be qualitative(e.g., indicating the presence of the target biological analyte) orquantitative (i.e., a measurement of the amount or concentration of thetarget biological analyte). In such embodiments, the transducer mayoptionally produce an optical, thermal or acoustic signal.

In any case, the signal may also be durable (i.e., stable and readableover a length of time typically at least of the same magnitude as theusage life of the article) or transient (i.e., registering a real-timemeasurement). Additionally, the signal may be transmitted to a remoteindicator site (e.g., via a wire, or transmitter, such as an infrared orrf transmitter) including other locations within or on the article orremote devices. Further, the biosensor 60, or any of its components, maybe adapted to detect and/or signal only concentrations of the targetbiological analyte above a predefined threshold level (e.g., in caseswherein the target biological analyte is normally present in the bodilywaste or when the concentration of the analyte is below a known “danger”level).

As described above, the target analytes that the biosensors of thepresent invention are adapted to detect may be pathogenic microorganismssuch as the pathogenic microorganisms implicated in humangastrointestinal diseases, especially those resulting in diarrhea. Thistype of pathogen is particularly important to monitor due to the numberof children who become seriously ill or die each year from diarrhealdiseases. It has been found that severe chronic diarrhea may result inweight loss and permanent physical and mental developmental retardation.A non-limiting list of pathogenic bacteria that the biosensor 60 maydetect include any of the various pathogenic strains of Escherichia coli(commonly known as E. coli); Salmonella strains, including S. typhi, S.paratyphi, S. enteriditis, S. typhimurium, and S. heidelberg; Shigellastrains such as Shigella sonnei, Shigella flexneri, Shigella boydii, andShigella dysenteriae; Vibrio cholerae; Mycobacterium tuberculosis;Yersinia enterocolitica; Aeromonas hydrophila; Plesiomonas shigelloides;Campylobacter strains such as C. jejuni and C. coli; Bacteroidesfragilis; and Clostridia strains, including C. septicum, C. perfringens,C. botulinum, and C. difficile. A non-limiting example of a commerciallyavailable biosensor adapted to detect E. coli is available from AndCare,Inc. of Durham, N. C., as test kit #4001. ABTECH, Scientific, Inc., ofYardley, Pa. offers “bioanalytical biotransducers”, available as BBAu-1050.5-FD-X, which may be rendered biospecific (for microorganisms orother target biological analytes as described herein) by covalentlyimmobilizing polypeptides, enzymes, antibodies, or DNA fragments totheir surfaces. Other suitable microbial biosensors are described inU.S. Pat. No. 5,869,272 (gram negative organisms); U.S. Pat. No.5,795,717 (Shigella); U.S. Pat. Nos. 5,830,341; 5,795,453; 5,354,661;5,783,399; 5,840,488; 5,827,651; 5,723,330; and 5,496,700, all of whichare incorporated herein by reference.

The target analytes that the biosensors of the present invention areadapted to detect may also be viruses. These may includediarrhea-inducing viruses such as rotavirus, or other viruses such asrhinovirus and human immunodeficiency virus (HIV). An exemplarybiosensor adapted to detect HIV is described in U.S. Pat. Nos. 5,830,341and 5,795,453, referenced above. The disclosure of each of these patentsis incorporated by reference herein.

In alternative embodiments, the target analytes that the biosensors ofthe present invention are adapted to detect may also be parasites,especially those which inhabit the gastrointestinal tract during somepoint in their life-cycle. Such parasites may include protozoans, worms,and other gastrointestinal parasites. Other examples of parasites whichmay be detected include entamoeba histolytica (which cause amoebicdysentery), trypana cruzi (which causes Chagas disease), and plasmodiumfalciparum.

In yet other embodiments, the target analytes the biosensors of thepresent invention are adapted to detect may fungi such as Candidaalbicans. In addition to pathogenic bacteria, certain beneficial colonicbacteria may be detected and/or measured as a health indicator, such asBifidobacteria and Lactobacillus strains.

The target analytes that the biosensors of the present invention areadapted to detect may also be proteins or antigens related to skindistress. Preferably, these analytes are detectable on or at the skinsurface, preferably prior to the presentation of clinically observableskin irritation. These may include stress proteins such as cytokines,histamine, and other immune response factors including interleukins(such as IL-1α, IL-2, IL-3, IL-4, and IL-8) and interferons (includinginterferons a and g). Again, these are preferably detectable by thebiosensor 60 prior to the onset of clinically observable redness,irritation, or dermatitis. Additionally, the biosensors of the presentinvention may be adapted to detect enzymes, or other biological factors,implicated in skin irritation (e.g., diaper dermatitis), includingtryspin, chymotrypsin, and lipase.

The biosensors of the present invention may also comprisebio-recognition systems, including enzymes or binding proteins such asantibodies immobilized onto the surface of physico-chemical transducers.For example, a specific strain of bacteria may be detected viabiosensors employing antibodies raised against that bacterial strain.Alternatively, a target bacteria may be detected by a bio-recognitionelement (including antibodies and synthetic or natural molecularreceptors) specific to extracellular products of the target bacteria,such as toxins produced by that strain (e.g., E. coli). Exemplary enzymeelectrodes that may be used to detect phenols (e.g. in urine or feces)include tyrosinase based electrodes or polyphenol oxidase enzymeelectrodes described in U.S. Pat. No. 5,676,820 entitled “RemoteElectrochemical Sensor,” issued to Joseph Wang et al. on Oct. 14, 1997and U.S. Pat. No. 5,091,299 entitled “An Enzyme Electrode For Use InOrganic Solvents,” issued to Anthony P. F. Turner et al. on Feb. 25,1992, respectively. Both of these patents are incorporated by referenceherein.

In any of the foregoing examples, the specific microorganism may bedirectly detected or may be detected by binding a toxin, enzyme, orother protein produced by the organism or an antibody, such as amonoclonal antibody, specific to the organism. Exemplary biosensorsadapted to detect proteolytic enzymes described in U.S. Pat. No.5,607,567 and toxins in U.S. Pat. Nos. 5,496,452; 5,521,101; and5,567,301.

The biosensor 60 of the present invention may comprise one or more“proactive sensors”. This is especially useful in embodiments where thedetection of the target biologically reactive analyte precedes the onsetof clinically observable health symptoms. As used in this application,the term “proactive sensor” refers to a sensor that is capable ofdetecting changes or signals on the body of the wearer (i.e., skin) orin the waste, i.e., inputs, that directly relate or, at a minimum,correlate to the occurrence of an impending or potential health or skinrelated even. Proactive sensors may respond to one or more specificinputs as described above.

A proactive sensor 60 may detect an impending event or detect aparameter that directly relates, or at a minimum correlates to theoccurrence of an impending event, particularly a systemic or skin healthevent or condition (i.e., the presentation of clinically observableindications or symptoms). An impending event that may be detected orpredicted by a proactive sensor 60 of the present invention may includediarrheal disease, skin irritation or rash (including candidiasis),and/or other types of illness or medical conditions of the wearer suchas a parasitic infestation. The detected biological analyte may be oneor more steps removed from the actual presentation of clinical symptoms.For example, the biosensor may detect potential precursors to the aboveconditions (e.g., fecal contamination of the skin that may precede theelicitation of stress proteins which may, in turn, precede clinicallyobservable skin irritation. A parameter that correlates to an event isany measurable input, signal such as one or more of the potential inputslisted above, that correlates with the occurrence of the event withinthe frame of reference of the system (i.e., a signal caused by the wasteor the wearer). Proactive sensors 60 in an article may measure one ormore different inputs in order to predict an event. For example, theproactive sensor 60 may monitor for Candida albicans in the feces andresidual colonic bacteria on the skin (i.e., detecting residualcontamination) both of which are signals that may precede skinirritation.

In biosensor embodiments wherein the bio-recognition element does notproduce an easily visible signal (e.g., a color change), the biosensor60 may include a transducer in communication with the bio-recognitionelement in order to convert the physico chemical signal from thebio-recognition element into a usable signal to the wearer, caretaker,or component of the article (e.g., and actuator). Exemplary transducersmay include electrochemical transducers (including potentiometric,amperometric, and conductimetric transducers), optical transducers(including fluorescence, bioluminescence, total internal reflectiveresonance, and surface plasmon resonance), thermal transducers, andacoustic transducers, as known in the art. A power source, such as aminiature 3 volt watch battery or printed thin film lithium battery, maybe connected with the biosensor 60 to provide any required power.

The effectiveness of the biosensors of the present invention may bemeasured with the Response Factor Test described in the Test Methodsection below. The Response Factor describes the ratio of the responseof the biosensor when exposed to fecal test material compared to theresponse of the biosensor when exposed to physiological saline solutionand is useful in assessing the sensitivity of the biosensor forbiologically active analytes expected to be found preferentially infeces versus urine. The biosensors of the present invention preferablyhave a response factor of at least 2, 3, or 5, more preferably at least10, and even more preferably at least 20 when exposed to fecal testmaterial in aqueous solution or test urine having a concentration of 1gram of fecal test material per 1 gram of physiological saline solution.(Physiological saline solution is used here to represent the backgroundinput signal which is present in most natural environments such asaqueous body fluids.) Such biosensors are able to clearly distinguishbetween the presence of fecal material and the presence of physiologicalsaline solution with respect to a target biologically active analytespecific to feces.

One way to detect feces is to detect skatole, a substance commonly foundin fecal material. It has been found that the skatole concentration infeces is about 180 microgram per gram of fecal material whereas theskatole level in urine has been found to be substantially lower. Skatoleis generally a product of microbiological degradation that originatesfrom the catabolism of tryptophane in the intestinal system.

In one preferred embodiment of a skatole detecting biosensor, thebiosensor comprises genetically engineered microorganisms whichassimilate skatole and or other substances. The assimilation of skatolespecific substances can be measured, for example, via the oxygenconsumption during the assimilation process. Microorganisms suitable fordetecting skatole include Acinetobacter baumannii T0136 (FERM P-12891,Japanese patent publication JP05304947), and Bacillus sp T0141 (FREMP-12914, disclosed in Japanese patent publication JP05304948). Suitablebiosensors including such microorganisms are commercially available forexample from Institut für Chemo-und Biosensorik of Münster, Germany,under the designation Mikrobielle Sensoren.

If microorganisms are incorporated into a biosensor, they may beimmobilized in the biosensor by techniques known in the art such asentrapment, adsorption, crosslinking, encapsulation, covalentattachment, any combination thereof, or the like. Further, theimmobilization can be carried out on many different substrates such asknown the art. In certain preferred embodiments, the immobilizationsubstrate may be selected from the group of polymer based materials,hydrogels, tissues, nonwoven materials, woven materials.

In certain embodiments, the sensor 60, including any biosensorembodiments, may comprise, be disposed on, or be operatively associatedwith a microchip, such as a silicon chip, MEMs (i.e., microelectromechanical system) device, or an integrated circuit.Microchip-based biosensors may be known as “biochips”. Regardless of thetype of sensor, the microchip may comprise a multiplicity of sensorcomponents having similar or different sensitivities, kinetics, and/ortarget analytes (i.e., markers) in an array adapted to detect differinglevels or combinations of said analyte(s). Further, each sensor in suchan array may provide a different type of signal, including those typesdisclosed herein, and may be associated with different actuators and/orcontrollers. Also, each sensor in an array may operate independently orin association with (e.g., in parallel, combination, or series) anynumber of other sensors in the array.

The biosensor 60 may be disposed in and/or operatively connected to anyportion of a disposable article that will be exposed to the input thatthe biosensor is designed to detect. For the purposes of the presentinvention, the term “operatively connected” refers to a means ofcommunication such that the biosensor 60 may signal some portion of thearticle 20 when the biosensor 60 detects an input. The biosensor 60 maybe separate from and operatively connected to another portion of thebiosensor 60, another biosensor 60, an actuator, a controller or someother portion or component of the article 20. “Operatively connected”may, for example, include a means of communication such as an electricalconnection via a conductive wire or member, via a transmitted signalsuch as radio frequency, infrared or another transmitted frequencycommunication. Alternatively, the biosensor 60 may be operativelyconnected via a mechanical connection such as a pneumatic or a hydraulicconnection.

In disposable article embodiments (e.g., diaper 20 of FIG. 1), thebiosensor 60 may be located in the front waist region 36, the rear waistregion 38 or the crotch region 37 of article 20, and may be integralwith, disposed adjacent to, joined to, or comprise a portion of thechassis 22, the topsheet 24, the backsheet 26, the absorbent core 28,side panels 30, leg cuffs 32, a waist feature 34, a fastening system 40,the longitudinal 50 or end 52 edges, etc. In certain preferredembodiments wherein the target biological analyte is associated withbodily waste, the biosensor to 60 may be disposed in the crotch regionof the article 20 so as to maximize the probability of the bodily wastecontacting the biosensor 60. In other preferred embodiments wherein thebiosensor is adapted to detect or measure a target biological agent onthe wearer's skin, the biosensor 60 may be disposed on the topsheet,cuff, a waist feature, a feces receiving pocket, spacer, or any otherportion of the article that will contact the wearer's skin during theusage process. In certain embodiments, the biosensor may also beassociated with the lotion or other skin care composition within thearticle.

The biosensor 60 may be integral with the article 20, or may beinstalled by the caretaker or the wearer. The biosensor during thecourse of wearing the article may also become at least partiallydetached from the article and may be adhered to the wearer's skin. Thebiosensor may be affixed, permanently or detachably (e.g., via amechanical fastening system like Velcro™ or a water soluble adhesive) toa support structure, including adhesive tapes, cellulosic or syntheticwebs, nonwoven highlofts, films, scrims, foams, and the like. Further,the biosensor 60 may be completely contained within the article such asarticle 20 or may have a receiving portion located in the article suchthat it will come into contact with the desired input and anotherportion such as a transmitting portion located either in the article oroutside the article. The biosensor 60 may be external to the article 20yet operatively connected to some portion of the article 20 such thatthe biosensor 60 may detect an input external to the article 20 andprovide a signal to a controller and/or an actuator. In someembodiments, the biosensor may be separate from the article, e.g.,separately applied to some portion of the wearer via adhesive or othermeans as known in the art, and/or may have one or more componentsseparate from the article.

In some embodiments, a wiping means or element may be provided to allowthe wearer or caretaker to clean sufficient bodily waste from thebiosensor 60 to allow a visual assessment or reading of the signal(especially for biosensor embodiments that provide such a signal). Thewiping element may include a web (cellulosic or synthetic), nonwovenhighloft, film, foam, rigid or semi-rigid squeegee like element, and thelike disposed in the article and adapted such that the element may beused to clean the biosensor display. The wiping element may be at leastpartially affixed the to a component of the article, such as a topsheet,in proximity to the biosensor 60 by any known means in the art. Thewiping means may optionally comprise water or any other known cleaningaid to facilitate cleaning of the wearer or the biosensor display.

In certain preferred embodiments, the article 20 also may comprise anactuator. As used in this application, the term “actuator” refers to adevice that comprises “potential” and a means of transforming thatpotential to perform or activate a “responsive function.” The potentialof the actuator may comprise either stored or potential energy or storedmaterial. The actuator thus may perform or activate a responsivefunction by transforming potential energy to kinetic energy or byreleasing or delivering a stored material. A “responsive function” isdefined for the purposes of the present invention as a functionperformed upon the bodily waste, the wearer, the article, or a componentor components thereof, or a signal to the wearer or the caretaker. Acomponent of bodily waste may include, for example, moisture,electrolytes, enzymes, volatile gases, bacteria, blood, etc. A componentof the wearer may also include skin, genitalia, the anus, the analsphincter muscle, etc. A component of the article may also include legcuffs, waist cuffs or other waste barriers and/or containmentcomponents, side panels, ears, a chassis, an absorbent core, anacquisition component, a fastening system, the longitudinal or endedges, etc. Potential energy may be stored as mechanical, electrical,chemical or thermal energy. “Kinetic energy” as used in this applicationrefers to the capacity to do work or to perform a responsive function asdescribed above (e.g., expansion of a compressed device, rotation of atwisted device, a gel that moves as it changes phases, coating ortreatment of skin or feces, inhibition of an enzyme, adjustment of pH,etc.).

Triggering the creation of a three dimensional structure to capturewaste, for example, involves responsive functions performed on acomponent of the article and, ultimately, on the waste. Capturing waste,wiping the skin of the wearer or treating the skin with a skin carecomposition, antimicrobial agent, antifungal agent or enzyme inhibitor,for example, are responsive functions performed on the waste and/or thewearer. Adjusting the article's geometry (in one, two or threedimensions) or physical properties (e.g., bending modulus, geometry,etc.) are examples of responsive functions, which may be performed onthe article. Signaling a caretaker and/or the wearer that an event hasoccurred, or is about to occur, is also considered a responsive functionfor the purposes of the present invention. The signal may be visual,auditory, tactile, electrical, chemical, or biological. An actuator of adisposable article may, for example, release or deliver a deodorant,enzyme inhibitor, antimicrobial agent, antifungal agent, skin carecomposition or pH control agent; capture, wipe, cover, trap, immobilize,seal, pump, or store bodily waste; or trigger the release or creation ofa structure or element designed to perform one or more of thesefunctions or any other responsive function upon the waste, wearer,article, or a component thereof.

The actuator of the present invention may release potential energy toperform or activate a responsive function upon the waste, the wearer,the article, or a component thereof. The release of potential energy maytransform mechanical, electrical, chemical or thermal potential energyinto mechanical, electrical or chemical kinetic energy to perform theresponsive function. Actuators may be triggered by a threshold level ofan input to release potential energy to perform a responsive function ormay respond continuously to an input as described below. For example, acompressed foam has stored compressive mechanical potential energy andmay provide mechanical kinetic energy when it is released. A twistedfoam has stored torsional mechanical potential energy that may providemechanical kinetic energy, i.e., rotation, when it is released. Inaddition, stored chemical, electrical or thermal energy may be used torelease electrical, mechanical, chemical or thermal kinetic energy. Theactuator of a disposable article, for example, may include one or moreof the following: stored lotion, anti-fungal or antimicrobial agents,feces modification agents, enzyme inhibitors, pH buffers, dyes,pressurized gas, a compressed foam, a twisted foam, a pump, a closedsystem liquid transport member, an electrically sensitive gel, a pHsensitive gel, a salt concentration gel, etc. Potential energy may bestored in any manner sufficient to maintain or restrain it until it isrequired. Suitable means for maintaining and/or restraining such energyinclude batteries and/or capacitors, elastically, torsionally,compressively tensioned materials or structures in the form of unreactedreagents, and materials capable of performing physical or chemicalfunctions (e.g., absorbents, emollients, pH buffers, enzyme inhibitors,feces modification agents; compressed gases, etc.).

Alternatively, the actuator of the present invention may comprise aquantity of a stored material that has the capacity to perform oractivate a responsive function upon the waste, the wearer, the article,or any component or components thereof. In one embodiment, for example,the actuator may release or deliver a stored material that performs aresponsive function. In this embodiment, the actuator may be triggeredby a threshold level of an input to discontinuously release or deliverthe stored material at a given time or may release or deliver thematerial continuously. The actuator may, for example, include storedlotion, skin care compositions, antifungal or antimicrobial agents,feces modification agents, enzyme inhibitors, pH buffers, dyes, etc. Incertain preferred embodiments, the material may be delivered by anactuator such as an expanding resilient material, a released highpressure gas, etc.

FIGS. 2 and 2A illustrate an actuator 90 comprising a compressedresilient material 94, such as a foam, sealed under at least a partialvacuum within a pressure differentiation device 91. A pressuredifferentiation device, as used herein, is any device or structure thatcan maintain a resilient material in a compressed state (e.g., can storeenergy by providing a constraining pressure on the compressed resilientmaterial 94). A “compressed state” is defined as the condition in whicha material is maintained at a smaller volume than the material wouldhave if unconstrained and under zero applied pressure. With respect toresilient materials, a compressed state may generally be achieved byapplying a pressure to a surface of the material or via any other meansknown in the art. The pressure differentiation device may, for example,comprise a vacuum sealed bag or tensioned materials, such as elastic orinelastic bands or strands, strips, films, nonwoven, scrims, or foams,that constrain a resilient material. Preferably, the compression of theresilient material maintained by the pressure differentiation device 91may be at least partially reduced (i.e., the compressed resilientmaterial 94 may at least partially expand) via a trigger mechanism. Atrigger mechanism is any element or device, such as a sensor, actuator,or combination thereof, that responds to an input to effect theequalization of pressure in the pressure differentiation device 91 andallow the compressed resilient material 94 to at least partially expand.Upon release of the compressed material, such as when a targetbiologically active analyte is detected, the compressed resilientmaterial may expand and deliver the stored material. In someembodiments, it may be advantageous for the actuator 90 to comprise avoid space 96.

The resilient material 94 may comprise any resilient material, includingbut not limited to, an EVA foam such as the ones available from FoamexCorporation of Eddystone, Pennsylvania identified as SIF/210PPI orAquazone 80A foam, or from Sentinel Products Corporation of Hyannis,Mass. identified as MC1900 EVA 2 lb/ft³, or a HIPE foam as described inU.S. Pat. No. 5,260,345 entitled “Absorbent Foam Materials For AqueousBody Fluids and Absorbent Articles Containing Such Materials” issued toDesMarais et al. on Nov. 9, 1993; U.S. Pat. No. 5,387,207 entitled“Thin-Until-Wet Absorbent Foam Materials For Aqueous Body Fluids AndProcess For Making Same” issued to Dyer et al. on Feb. 7, 1995; and U.S.Pat. No. 5,625,222 entitled “Absorbent Foam Materials For Aqueous FluidsMade From high Internal Phase Emulsions Having Very High Water-To-OilRatios” issued to DesMarais et al. on Jul. 22, 1997. (Each of thepatents identified above is incorporated by reference herein.)

In some embodiments of the present invention, the pressuredifferentiation device 91 may comprise a bag, such as soluble bag 92.The soluble bag 92 may be soluble in the presence of one or moredifferent types of input, such as water, urine, fecal enzymes, a pHlevel, etc., and may have physical and/or chemical characteristics(e.g., thickness) that may be designed to set a threshold level of thatinput required to dissolve the bag. The soluble bag may, for example,comprise a plastic film that is soluble to water such as PVA filmssupplied by Chris-Craft Industrial Products, Inc. of South Holland, Ill.as MONOSOL M7031, M7030, M8630, M8534, or E6030 film, or H. B. FullerCompany of St. Paul, Minn. as HL 1636 or HL 1669-X. The film thickness,for example, may also be modified to provide a desired activation. Thefilm used may, for example, also have a thickness in the range fromabout 0.0005 to about 0.0015 inches. An HL 1636 film having a thicknessof about 0.001 inches, for example, will activate with a moisturecontent of about 0.049 grams per square inch.

The actuator may alternatively comprise an electrically sensitive gel.Electrically sensitive gels are polymeric gel networks that, when atleast partially swollen with water, change volume and/or geometry underthe application of an electric current or field. For example, certainpartially ionized polyacrylamide gels will undergo anisotropiccontraction of about 50% under weak electric fields (e.g., 0.5 volts/cm)when immersed in acetone and water. Alternative electrically sensitivegels may undergo electrically induced bending in the presence of waterand a surfactant or may undergo an oscillating wave motion whensubjected to an oscillating electric field. It is believed that localshrinkage may be induced in a portion of the gel, e.g., one side of agel element, by concentrating positively charged surfactant molecules onthe negatively charged gel polymer in an electric field. Changing theintensity and/or the polarity of the field induces a movement in the gelas one side decreases in length (e.g., a gel formed in a strip maycurl). Electrically sensitive gels may comprise variable geometries suchas rectangular, circular, reticulated grid, etc. patterns in order toprovide a valve to release a material, allow a bodily waste to flowthrough, prevent a bodily waste from flowing through, encapsulate abodily waste, etc. as they change volume and/or geometry. Anelectrically sensitive gel formed in a strip, for example, may be bentto provide an available void space for when electrical activity in theexternal anal sphincter muscle predictive of defecation or urination isdetected.

In FIGS. 5A and 5B, for example, a strip of electrically sensitive gel494 is shown in a circuit in which fecal moisture may bridge thecontacts 485 and allow current to flow to the electrically sensitive geleither bending or straightening the strip. Alternatively, anelectrically sensitive gel 594 formed in a reticulated grid pattern 595,such as shown in FIGS. 6A, 6B and 6C, may be electrically induced toswell or shrink when an imminent urination is detected to form a valvethat allows and/or prevents urine flow to another portion of the article20. FIG. 6A, for example, shows a circuit including a reticulated gridpattern of an electrically sensitive gel. FIGS. 6B and 6C further show amicroscopic view of the grid in a shrunk and in a swelled configuration,respectively. An exemplary material is a weakly cross-linked PAMPs gel(poly(acrylamido-2-methyl propane) sulphonic acid). This type of gel mayperform various functions such as applying or delivering a chemicalfeces treatment agent. Other exemplary electrically sensitive gels aredescribed in U.S. Pat. No. 5,100,933 issued to Tanaka on Mar. 31, 1990and WO 9202005, both of which are incorporated by reference herein.Alternatively, pH sensitive gels or salt concentration sensitive gelsthat change volume and/or geometry at specific pH or saltconcentrations, respectively, may be used as an actuator of the presentinvention.

The actuator may be disposed in and/or operatively connected to anyportion of disposable article that will allow the actuator to perform aresponsive function upon the bodily waste, the wearer, the article, or acomponent thereof. In article 20, for example, the actuator may belocated in the front waist region 36, the rear waist region 38 or thecrotch region 37 of article 20, and may be integral with, disposedadjacent to or joined to a component of the chassis 22, the topsheet 24,the backsheet 26, the absorbent core 28, side panels 30, leg cuffs 32, awaist feature 34, a fastening system 40, the longitudinal 50 or end 52edges, etc. The actuator may also be completely contained within thearticle such as article 20, may have a portion located in the articleand a portion located outside the article 20, or may be completelyexternal to the article 20. An actuator or a portion of an actuator maybe operatively connected to one or more biosensors 60, one or morecontrollers 80, another portion of the actuator or another portion ofthe article 20. Further, the actuator may be integral with the article20, or may be installed by the caretaker or the wearer.

The article 20 may also include a controller. A “controller” is definedfor the purposes of this application as a device that receives an inputfrom a biosensor and determines if one or more actions are to be taken.The controller may receive a signal from the biosensor 60 and direct theactuator to perform a responsive function upon the bodily waste, thewearer, the article or a component thereof. Alternatively, the actuatormay receive the signal directly from the biosensor 60 and perform aresponsive function upon the wearer, the waste, the article or acomponent thereof. The controller may include materials that undergochemical or physical change, may be a chemical, mechanical or electricaldevice that processes information from a biosensor, etc. The controllermay include a transducer comprising a polylayer Langmuir-Blodgett film,wherein one or more layers includes a bio-recognition element. Uponcontact with water, Langmuir-Blodgett films are known to spontaneouslyreorganize, resulting in regions with more layers than the original filmand other regions having fewer layers. This reorganization may exposethe bio-recognition element to the environment preferentially in thepresence of water, such as in bodily waste, which may contain the targetbiological analyte. Thus, the number of false positives can be reducedand the shelf-life of the biosensor can be extended. Alternatively, anelectrical controller that receives signals such as electrical potentialfrom an electrochemical biosensor may receive and monitor multipleelectrical signals and may repeatedly trigger the actuator. Thecontroller may be integral with the biosensor component, integral withthe actuator component, or a separate component of the system.

The controller may be disposed in and/or operatively connected to anyportion of a disposable article that will allow the controller toreceive a signal from the biosensor 60 and to provide a signal to theactuator. In article 20, for example, the controller may be located inthe front waist region 36, the rear waist region 38 or the crotch region37 of article 20, and may be integral with, disposed adjacent to orjoined to the chassis 22, or a component of the topsheet 24, thebacksheet 26, the absorbent core 28, side panels 30, leg cuffs 32, awaist feature 34, a fastening system 40, the longitudinal 50 or end 52edges, etc. The controller may be integral with the article 20, or maybe installed by the caretaker or the wearer. The controller may becompletely contained within the article such as article 20, may have aportion located in the article and a portion located outside thearticle, or may be located completely outside the article 20. Thecontroller or a portion of a controller may be operatively connected toone or more biosensors 60, one or more actuators 90, another portion ofthe controller or another portion of the article 20. The controller, forexample, may receive a signal from the biosensor 60 and provide a signalto the actuator, e.g., by a radio frequency (rf) transmission.

Although distinct structural elements may perform the biosensor 60,actuator and controller functions, the biosensor 60, actuator and/orcontroller functions of the present invention need not be performed bydistinct structural elements. The biosensor 60 and controller functions,for example, may be performed by the same structural element.

A “responsive system” is defined for the purposes of this application asa system that includes a biosensor 60 and an actuator that acts upon thebodily waste, the wearer, the article, or a component or componentsthereof when the biosensor 60 detects the appropriate triggering input.Upon sensing a given input parameter, the actuator affects the releaseof stored energy or the release or delivery of stored material toperform a responsive function. For example, when a proactive biosensor60 including a transducer detects an impending event, the transducerprovides a signal to the actuator affecting the release of storedenergy. By detecting an input signal prior to the impending event, aresponsive system in the article may be triggered to prepare for theevent or to signal the caregiver or the wearer of the impending event.This allows construction of articles in which the waste-management ortreating technology is initially “hidden” or unobtrusive, but which isavailable at, or just before, the moment of need and/or in which thearticle may provide the caregiver or the wearer the opportunity toprepare for an event in advance (e.g., administer a prohylactictreatment to the wearer in the event of detected pathogenicmicroorganisms or residual fecal contamination). Regardless of thespecific input, the biosensor 60 in these embodiments may trigger anactuator to perform an action on the article, the wearer or theenvironment to prepare for the occurrence of the event or provide asignal to the caregiver that the impending event is about to occur. Ifthe biosensor 60 comprises a sensing system, one actuator may betriggered by different biosensors and/or signals, or different actuatorsmay be triggered by different biosensors and/or signals. Alternatively,one biosensor and/or signal may trigger multiple actuators.

A responsive system may respond in either a “continuous” or a“discontinuous” manner. As used in this application, a “continuousresponsive system” refers to a responsive system in which the output isquantitatively dependent upon the quantity of the input, i.e.,continuously increasing quantities of the input are required to affectcontinuously increasing quantities of the output, or where the output ofthe responsive system comprises a passive release of a stored material.A super absorbent polymer placed in an absorbent core of an article, forexample, provides a continuous response in which the output isquantitatively dependent upon the quantity of the input, i.e., asincreasing quantities of liquid waste contact the super absorbentpolymer, an increasing amount of the polymer contains that liquid untilthe capacity of the polymer is exhausted. A stoichiometric chemicalreaction is another example of a system having a continuous response toincreasing output. In the reaction A+excess B→C, for example, the amountof excess B converted to C is stoichiometrically and, therefore“continuously,” related to the amount of A available in the system.

A “discontinuous responsive system” of the present invention, however,refers to a responsive system that has an output function that isessentially independent of the quantity of the input beyond a thresholdlevel. For example, when one or more threshold levels of a given inputare met, the responsive system may release all or a pre-designatedportion of its stored energy or deliver, i.e., actively transport, allor a pre-designated portion of its stored material to perform a specificresponsive function. In an ideal embodiment of the present invention,the output function, f(x), includes a “step” function as shown in FIG.3A. In this embodiment, the rate of change in the output with increasinglevels of input (d(output)/d(input)), i.e., the slope or firstderivative f′(x) of the output function f(x), is preferably essentiallyzero when the amount of input is above or below the threshold level. Atthe threshold level, however, the d(output)/d(input) rate of changepreferably approaches infinity. Thus, in the ideal discontinuousresponse, the limit of the function f(x−ε) as ε→0 is not equal to thelimit of the function f(x+ε) as ε→0, i.e.,

${\underset{ɛ\rightarrow 0}{\lim\;}\;{f\left( {x - ɛ} \right)}} \neq {\lim\limits_{ɛ\rightarrow 0}{{f\left( {x + ɛ} \right)}.}}$

The present invention, however, recognizes that in the physical world anideal instantaneous step change at the threshold level is not necessaryand may not even be possible in many instances. In a preferredembodiment, it is only necessary that the output function have a virtualstep change with very little change in the input at or around thethreshold level of the input. Thus, the present invention contemplates adiscontinuous responsive system of the present invention having anoutput function that responds in a sufficiently discontinuous manner inthe transition region such that the output function has at least aminimum relative degree of steepness in the transition region. While notwishing to be limited to a particular method of describing or modeling adiscontinuous system, in a preferred method of determining whether agiven output function performs in a sufficiently discontinuous manner asdefined for the purposes of the present invention, the slope of theoutput curve at the inflection point is compared with the relative slopeof a line between the first and last points of the transition region.For example, FIG. 4A shows a graph of an exemplary output function, f(x)along with aligned graphs of the first, f′(x), and second, f″(x), andthird, f′″(x), derivatives of the exemplary output function. The outputfunction f(x) describes the effect of the in put (x or I) on the outputor response (R(I)). For purposes of the present invention, thetransition region is defined as the region between the relative maxima,R(I₁), and the minima, R(I₂), of the second derivative, f″(x), of theoutput function, f(x). The relative maxima, R(I₁), and the relativeminima, R(I₂), are points at which the third derivative, f′″(x), equalszero. The inflection point, I₀, is defined as the point in thetransition region at which the second derivative, f″(x), equals zero,i.e.,

${\frac{\mathbb{d}^{2}R}{\mathbb{d}I^{2}}\begin{matrix}❘ \\❘ \\❘\end{matrix}\begin{matrix}\; \\\; \\{I = I_{0}}\end{matrix}} = 0.$The comparison of the slope of the output function at the inflectionpoint to the slope of a line between the first and the last points ofthe transition region can be described by the equation:

${\frac{\mathbb{d}R}{\mathbb{d}I}\begin{matrix}{❘\mspace{65mu}} \\{❘\mspace{65mu}} \\{{❘I} = I_{0}}\end{matrix}} = {k{\frac{\left( {\Delta\; R_{T}} \right)}{\left( {\Delta\; I_{T}} \right)}.}}$In this equation dR/dI at the inflection point is the first derivativeof the output function at that point. The term ΔI_(T) is the change inthe input to the responsive system between the first, I₁, and last, I₂,points of the transition region, i.e., I₂-I₁, and the term ΔR_(T) is thechange in the response of the output function between the first and lastpoints of the transition region, i.e., R(I₂)-R(I₁). The coefficient k isa proportional constant that describes the relative steepness of theslope of the output function at the inflection point, I₀, compared tothe slope of a line between the first and last points of the transitionregion. In order that the responsive system have a discontinuous outputfunction, the proportional constant k must be at least about 2.0,preferably at least about 3.0, more preferably at least about 5.0, evenmore preferably at least about 10.0, with at least about 100.0 being themost preferred.

In certain embodiments, the relative degree of steepness in thetransition region of a discontinuous responsive system may also bemodeled by a transfer function of a control system having a series of aninteger number, n, first order lags with an equal time constant. Thetransfer function of the responsive system is defined for the purposesof the present invention as the ratio of the Laplace transforms of theoutput (responding variable) to the input (disturbing variable). See,e.g., Robert H. Perry & Don Green, Perry's Chemical Engineers' Handbook,Sixth Ed., Chap. 22 (McGraw Hill, Inc. 1984). As shown in FIG. 4B, therelative degree of steepness of an output function may be approximatedby the formula: KG(s)=K/Ts+1)^(n) in which KG(s) is the transferfunction, K is a proportional element, T is the time constant of thesystem, and n is the integer number of first order time lags. In thismodel, as the number n increases, the steepness of the output functionin the transition region increases, and the model begins to approximatea discontinuous responsive system. Certain discontinuous responsivesystems of the present invention preferably may be modeled by the aboveformula when n is greater than or equal to about 25, with n beinggreater than or equal to about 50 being more preferred, and n beinggreater than or equal to about 100 being the most preferred.

As shown in FIG. 3A, a responsive system of the present invention mayinclude a single threshold level at which the responsive system mayrelease all of its stored energy to perform a specific responsivefunction or may include multiple threshold levels at which the systemmay release a pre-designated portion of its stored energy to perform oneor more specific responsive functions at each of the threshold levels.In an embodiment having a single threshold level, for example, theresponsive system may release all of its stored energy to perform theentire responsive function when that threshold level is met. In such asingle threshold embodiment, In this example, the discontinuousresponsive system includes a system that has two states such as on oroff. When a threshold quantity of an input such as a target biologicalmaterial is present in the absorbent article, the responsive system mayperform a single responsive function upon the waste, the wearer, thearticle or a component thereof, such as enveloping the waste away fromthe skin of the user or providing an easily detectable visual signal tothe wearer or caregiver. Thus, the discontinuous responsive system mayperform a one-time “switch-like” function that changes from one state toanother in the presence of a threshold level of an input.

Alternatively, as shown in FIG. 3B, the responsive system may havemultiple threshold levels at which when each threshold level is met thesystem may release a given “quanta” of energy or deliver a givenquantity of material to perform a specific responsive function. In thisembodiment, when each threshold level is met, a portion of the entireresponsive function may be performed and/or different independentresponsive functions may be performed in response to different thresholdlevels being met. For example, a responsive system may monitor a fecalenzyme and when each threshold enzyme level is met may deliver an equalor unequal quantity of enzyme inhibitor(s) or lotion, or deliver a pHbuffer at the first threshold level and perform another responsivefunction such as delivering a quantity of enzyme inhibitor(s) at thesecond threshold level. In each transition region, the responsive systemresponds essentially the same as the transition region in the singlethreshold embodiment described above.

In addition, a responsive system may monitor multiple inputs such as oneor more pathogenic bacteria and/or one or more fecal enzymes and performone or more responsive functions when the threshold levels of thedifferent inputs are met or may perform one responsive function onlywhen two or more of the threshold levels of the different inputs aremet. Thus, a controller may monitor multiple different inputs andperform a different responsive function when the threshold level of thedifferent inputs are met. Alternatively, the controller may perform alogic OR-gate type function such that a responsive function may beperformed when one or more threshold levels of the multiple inputs aremet. The controller may also perform a logic AND-gate type function suchthat a responsive function may be performed when each threshold level oftwo or more different inputs is met.

The responsive system may also comprise a “closed loop” or an “openloop” system. A “closed loop” system, which is also referred to as a“feedback control loop” system, includes distinct biosensor 60 andactuator components and performs a responsive function upon the input.In some preferred embodiments, the system may also use a detection or ameasurement of an element or a parameter of the output condition as atleast one trigger of the responsive function that is performed upon theinput. The output condition may be the state of the input conditionafter the actuator has had the opportunity to perform a responsivefunction on the input condition. The responsive function may beperformed when the output condition reaches a threshold level, or may beperformed only when the output condition and one or more otherconditions are met. Acting upon the input may include acting upon theelement sensed, e.g., sensing a microorganism and acting upon themicroorganism, or may include acting upon a composition of which theelement sensed is an integral component, e.g., sensing a fecal bacteriaand acting upon the fecal mass or residual feces on the wearer's skin Asdescribed above, a feedback control loop system includes at least twodistinct components: the biosensor 60 and the actuator. The biosensor 60detects an event, or a parameter associated with that event. Theactuator receives a signal and performs a responsive function on theinput condition detected by the biosensor 60. The feedback control loopmay further include a controller. In this case, the biosensor 60 mayprovide a signal to the controller, and the controller may direct theactuator to perform a responsive function upon the input condition. Thecontroller may be a separate component of the responsive system or thecontroller function may be performed by the biosensor 60 and/or theactuator.

The feedback control loop may be “non-modulating” or “modulating.” In a“non-modulating” feedback control loop responsive system the responsivesystem acts as a one-time switch in which the actuator performs aresponsive function on the input when the threshold level of the outputcondition is met. For example, the biosensor 60 may detect the presenceof or measure the concentration of a specific pathogenic microorganism,and the actuator may signal the caretaker of a potential incipientinfection. In this example, the actuator acts upon the input detected bythe biosensor 60. A “modulating” feedback control loop, however,includes a biosensor 60, an actuator and a controller. In a modulatingfeedback control loop, the output condition is monitored constantly orrepeatedly, and the controller directs the actuator to perform aresponsive function on the input in order to maintain the outputcondition at a desired set point or within a desired range or to providea continuous measurement of the level or concentration of the targetbiological analyte.

An “open loop” system, however, is a system that responds to the inputto perform a responsive function without using feedback, i.e., theoutput has no effect upon the sensed input entering the system. An openloop system may include a responsive system that has a single devicethat performs the functions of both the biosensor 60 and the actuator ormay have distinct biosensor 60 and actuator components in which theactuator acts upon something other than the input. A super absorbentpolymer placed in an absorbent core of a disposable absorbent article,for example, provides an open loop response because the polymer onlyincludes a single device that performs the functions of the biosensor 60and actuator. Alternatively, an open loop responsive system may includea biosensor 60 that detects bodily waste or a component of that bodilywaste, and an actuator that performs a responsive function in acontinuous or a discontinuous manner on something other than the inputdetected by the biosensor 60.

The present invention includes responsive systems that provide adiscontinuous or continuous response, whether open loop or closed loop.Other responsive systems are described in U.S. patent application Ser.Nos. 09/106,424 entitled “Disposable Article Having A DiscontinuousResponsive System” filed on Jun. 29, 1998 (P&G Case Number 7197); Ser.No. 09/107,563 entitled “Disposable Article Having A Responsive SystemIncluding A Feedback Control Loop” filed on Jun. 29, 1998 (P&G CaseNumber 7198); and Ser. No. 09/106,225 entitled “Disposable ArticleHaving A Responsive System Including A Mechanical Actuator” filed onJun. 29, 1998 (P&G Case Number 7199), each of which is incorporatedherein by reference.

An example of a diaper 20 of the present invention may include aresponsive system that includes a biosensor 60 as shown in FIG. 1 and anactuator as shown in FIG. 2. In this embodiment, the biosensor 60 maycomprise a transducer operatively associated with a bio-recognitionelement adapted to detect E. coli in feces. Upon the specific detectionof a threshold level of E. coli by the bio-recognition element, thetransducer signals the actuator with an electrical current. The articleshown in FIG. 1 may include an actuator that comprises a compressedresilient material 94 vacuum sealed under a water soluble film 91, asshown in FIG. 2 (e.g., a PVA film). Upon receipt of the proper signalfrom the biosensor 60, the actuator may close a switch, for example mayrelease a small amount of stored water to contact and dissolve the watersoluble film 91. This results in the release of the stored mechanicalenergy in the compressed foam. The resilient material 94 expands andforms a spacer to provide void volume for the incipient feces.Alternatively, the switch closure may additionally release anantimicrobial to control the E. coli and/or a visible dye to signal theE. coli presence to the wearer or caretaker. In another embodiment, theresponsive system may include an actuator that alerts the caretaker orthe wearer of an impending event such as a diarrheal infection or a skinirritation (e.g., candidiasis).

Test Method

Response Factor Test:

With the Response Factor Test as described hereafter, the response of aquantitative sensor as a reaction to exposure to a specific substance orcomposition can be measured.

The specific substances or compositions for which this test is suitableinclude: fecal test material in aqueous solution having a concentrationof 1 gram of fecal test material per 1 gram of physiological salinesolution; fecal test material in test urine solution having aconcentration of 1 gram of fecal material per 1 gram of test urinesolution; test urine solution; a solution of skatole in physiologicalsaline solution having a concentration of 180 micrograms of skatole pergram of physiological saline solution; physiological saline solution.

All measurements are carried at body temperature (37° Celsius). Themethod includes the following steps in the following order:

-   -   1) Record quantitative response of the sensor after exposure to        physiological saline solution for 24 hours. The background        response is the maximum recorded response.    -   2) Expose the sensor to specified substance or composition.    -   3) Record quantitative response of the sensor while sensor is        still exposed to the specified substance or composition for 24        hours. Substance response is the maximum recorded response.

The Response Factor is obtained by normalizing the substance responsewith the background response. In case the Response Factor is smallerthan 1, the reciprocal value of the Response Factor is reported as theResponse Factor (i.e., the response may be inversely correlated with theinput).

While particular embodiments and/or individual features of the presentinvention have been illustrated and described, it would be obvious tothose skilled in the art that various other changes and modificationscan be made without departing from the spirit and scope of theinvention. For example, although the present invention is illustratedand described primarily with respect to a disposable diaper, the presentinvention is not limited to this embodiment. The present invention mayalso be used, for example, in articles that are applied directly to awearer (e.g., to the perianal or perineal regions of the wearer) priorto the application of a disposable diaper or in place of a disposablediaper, in a pull-on diaper, a diaper insert, a sanitary napkin, atampon, etc. Further, it should be apparent that all combinations ofsuch embodiments and features are possible and can result in preferredexecutions of the invention. Therefore, the appended claims are intendedto cover all such changes and modifications that are within the scope ofthis invention.

1. A disposable article to be fitted to a wearer comprising: a biosensor including at least one biologically reactive bio-recognition element comprising a biologically derived material and adapted to detect or interact selectively with a specific microorganism selected from the group consisting of pathogenic bacteria, colonic bacteria, viruses, parasites and fungi, present in bodily waste or on the wearer's skin, the biosensor also being adapted to provide a signal of detection of the specific microorganism.
 2. The disposable article of claim 1 wherein the biosensor is selected from the group of: a biocatalytic biosensor and a bioaffinity biosensor.
 3. The disposable article of claim 2 wherein the bioaffinity biosensor is selected from the group of: a chemoreceptor-based biosensor and an immunosensor.
 4. The disposable article of claim 1 wherein the bio-recognition element is selected from the list including: an enzyme or sequence of enzymes; an antibody; DNA; an organelle; a membrane receptor protein; a natural or synthetic cell membrane; viable or nonviable bacterial, plant, or animal cells; at least a portion of a nerve bundle; at least a portion of a sensing organ.
 5. The disposable absorbent article of claim 4 wherein the bio-recognition element is selected from the group including Acinetobacter baumannii TOI36 and Bacillus sp TOI41.
 6. The disposable absorbent article of claim 5 wherein the bio-recognition element is disposed on a substrate selected from the group of: polymer based materials, hydrogels, tissues, nonwoven materials, and woven materials.
 7. The disposable article of claim 1 wherein the specific microorganism is selected from the group consisting of rotavirus, rhinovirus, human immunodeficiency virus, a parasite, and a pathogenic bacteria selected from the list: Escherichia coli; Salmonella typhi; Salmonella paratyphi; Salmonella enteriditis; Salmonella typhimurium; Salmonella heidelberg; Shigella sonnei; Shigella flexneri; Shigella boydii; Shigella dysenteriae; Vibrio cholerae; Mycobacterium tuberculosis; Yersinia enterocolitica; Aeromonas hydrophila; Plesiomonas shigelloides; Campylobacter jejuni; Campylobacter coli; Bacteroides fragilis; Clostridia septicum, Clostridia perfringens, Clostridia botulinum, and Clostridia difficile.
 8. The disposable article of claim 1 wherein the biosensor detects a target biological analyte associated with a systemic or skin health condition in the wearer prior to the onset of clinically observable symptoms of the condition.
 9. The disposable article of claim 1 wherein the biosensor detects a target biological analyte only above a pre-defined threshold level.
 10. The disposable article of claim 1 wherein the biosensor provides a signal to at least one of the group of: the wearer, a caretaker, an actuator.
 11. The disposable article of claim 10 wherein the signal is a visible indication.
 12. The disposable article of claim 10 wherein the signal is qualitative.
 13. The disposable article of claim 10 wherein the signal is quantitative.
 14. The disposable article of claim 10 wherein the signal is durable throughout at least the usage life of the article.
 15. The disposable article of claim 1 wherein the article additionally comprises a cleaning element for the biosensor.
 16. The disposable article of claim 1 wherein the biosensor is affixed to a support element.
 17. The disposable article of claim 1 wherein the support element adheres to the wearer's skin.
 18. The disposable article of claim 16 wherein the support element is an adhesive tape.
 19. The disposable article of claim 1 wherein the biosensor is detachable from the article.
 20. The disposable article of claim 1 wherein the biosensor adheres to the wearer's skin.
 21. The disposable article of claim 1 wherein the bodily waste is feces, urine or menses.
 22. The disposable article of claim 1 wherein the bodily waste is residual fecal contamination located on the wearer's skin.
 23. The disposable article of claim 1 further comprising an actuator that performs a responsive function when the biosensor detects a target biological analyte.
 24. The disposable article of claim 23 wherein the responsive function is a signal to a caretaker, or the wearer.
 25. The disposable article of claim 23 wherein the actuator transforms a potential energy to perform the responsive function, the potential energy being one or more selected from the group of: mechanical energy, electrical energy and chemical energy.
 26. The disposable article of claim 23 wherein the responsive function is one or more selected from the group of: creating a void volume, treating skin, creating a foaming system and signaling a caregiver.
 27. The disposable article of claim 1 further comprising a receiver.
 28. The disposable article of claim 27 wherein the receiver is integral with said article.
 29. The disposable article of claim 27 further comprising a transmitter.
 30. The disposable article of claim 29 wherein the transmitter comprises an infrared telemetry transmitter.
 31. The disposable article of claim 1 wherein the biosensor has a Response Factor of at least 5 when exposed to feces.
 32. The disposable article of claim 1 wherein the biosensor has a Response Factor of at least 10 when exposed to feces.
 33. The disposable article of claim 1 wherein the biosensor has a Response Factor of at least 20 when exposed to feces.
 34. The disposable absorbent article of claim 1 wherein the biosensor has a Response Factor of at least 5 when exposed to a solution of skatole in physiological saline solution having a concentration of 180 micrograms of skatole per gram of physiological saline solution.
 35. The disposable absorbent article of claim 1 wherein the specific microorganism is selected from the group consisting of rotavirus, rhinovirus, human immunodeficiency virus, a parasite, and a pathogenic bacteria selected from the list: Escherichia coli; Salmonella typhi; Salmonella paratyphi; Salmonella enteriditis; Salmonella typhimurium; Salmonella heidelberg; Shigella sonnei; Shigella flexneri; Shigella boydii; Shigella dysenteriae; Vibrio cholerae; Mycobacterium tuberculosis; Yersinia enterocolitica; Aeromonas hydrophila; Plesiomonas shigelloides; Campylobacter jejuni; Campylobacter coli; Bacteroides fragilis; Clostridia septicum, Clostridia perfringens, Clostridia botulinum, and Clostridia difficile.
 36. A disposable absorbent article to be fitted to a wearer comprising: a topsheet; a backsheet joined with the topsheet; an absorbent core disposed between the topsheet and the backsheet; and a biosensor disposed on the disposable article, the biosensor including at least one biologically reactive bio-recognition element comprising a biologically derived material and adapted to detect or interact selectively with a specific microorganism selected from the group consisting of pathogenic bacteria, colonic bacteria, viruses, parasites and fungi, present in bodily waste, the biosensor also being adapted to provide a signal of detection of the specific microorganism.
 37. The disposable absorbent article of claim 36 wherein the disposable article is chosen from the following group: a sanitary napkin, a diaper, a training pant and an adult incontinence device.
 38. The disposable absorbent article of claim 36 wherein the biosensor is selected from the group of: a biocatalytic biosensor and a bioaffinity biosensor.
 39. The disposable absorbent article of claim 38 wherein the bioaffinity biosensor is selected from the group of: a chemoreceptor-based biosensor and an immunosensor.
 40. The disposable absorbent article of claim 36 wherein the bio-recognition element is selected from the list including: an enzyme or sequence of enzymes; an antibody; DNA; an organelle; a membrane receptor protein; a natural or synthetic cell membrane; viable or nonviable bacterial, plant, or animal cells; at least a portion of a nerve bundle; at least a portion of a sensing organ.
 41. The disposable absorbent article of claim 36 wherein the biosensor adheres to the wearer's skin.
 42. The disposable absorbent article of claim 36 wherein the biosensor has a Response Factor of at least 5 when exposed to feces.
 43. The disposable absorbent article of claim 36 wherein the biosensor has a Response Factor of at least 10 when exposed to feces.
 44. The disposable absorbent article of claim 36 wherein the biosensor has a Response Factor of at least 20 when exposed to feces.
 45. The disposable absorbent article of claim 36 wherein the biosensor has a Response Factor of at least 5 when exposed to a solution of skatole in physiological saline solution having a concentration of 180 micrograms of skatole per gram of physiological saline solution. 